Slides
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< Q4 and FY 2025 Report Johannes Doll, CEO Johan Spetz, CFO February 12, 2025
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< Disclaimer Forward-looking statements This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Sedana Medical’s business, financial condition and results of operations. The terms “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “should”, “projects”, “will”, “would” or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realized. Factors that could cause these differences include, but are not limited to, implementation of Sedana Medical’s strategy and its ability to further grow, risks associated with the development and/or approval of Sedana Medical’s products candidates, ongoing clinical trials and expected trial results, the ability to further commercialize Sedaconda ACD and Sedconda (isoflurane), technology changes and new products in Sedana Medical’s potential market and industry, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Sedana Medical disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. 2
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< We have delivered on our ambition to reach full-year profitability ex-US 1 Excl. Fx 3 Achieve growth in our ex-US business • All-time-high FY net sales of 200 MSEK (+16%1 YoY) • Highest Q4 sales to date of 52 MSEK (+11%1 YoY) Reach break-even ex- US during 2025 • First-time positive EBITDA in our ex-US business (3% FY and 8% in Q4) • Positive group level EBITDA in Q4 • FY group level EBITDA improved by 12 percentage points YoY • GM stable at 71% for the full year, and 73% in Q4 • Cash of 91 MSEK end of 2025 Make headway towards US approval • Primary endpoint met and promising secondary endpoint results in both US trials • FDA approval for Early Access Program and FDA Fast Track Designation • Preparations of NDA submission progressing on time • Positive pre-NDA meeting Our 3 priorities
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< We have accomplished a successful turn-around after Covid-19 Net sales SEK million Successful restructuring after Covid-19 • Streamlined corporate headquarters and improved overall spend effectiveness • Shifted resources to the frontline • Steered investments towards profitable and growing markets • Implemented front-line effectiveness initiatives 4 159 123 154 179 200 2021 2022 2023 2024 2025 +16%1 1 Excl. Fx effects, 12% organic growth EBITDA SEK million -50 -80 -40 -17 6 2021 2022 2023 2024 2025 -83 -43 -31 -10 Ex-US Group
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< We have met our financial target for 2025 and set a new ambitious target for 2026 5 Financial Target 2025 Positive ex-US EBITDA (low-to-mid single digit range) Communicated target: +3% (+4% excl. FX effects) Result: Financial Target 2026 Mid-to-high single digit ex-US EBITDA and approaching group-level EBITDA profitability
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< With >30% growth, our ‘Other Direct Markets’ continued on their strong growth path 6 Net Sales MSEK 2024 2025 15,3 19,1 +25% Q4 2025 31% excl. Fx 2024 2025 52,6 67,0 +27% FY 2025 32% excl. Fx Comments • Spain continued to be the main growth engine, with an expanded team and a focused strategy to establish inhaled sedation as mainstay therapy in high-potential accounts. • UK saw a surge in demand during 2024, following the MHRA approval, but showed flat sales in 2025, due to a longer-term staff absence and too much focus on new potential customers at the expense of existing customers. Both issues are addressed and we saw growth in Q4. • France continued to show split performance, with growth in isoflurane accounts and sales decline in sevoflurane accounts following the SESAR study. >60% of SESAR sites have been switched to isoflurane. • Other Direct Markets represented 35% of Sedana Medical’s core business
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< Germany grew 3% in 2025, with two very different halves of the year 7 Net Sales MSEK 2024 2025 29.662 26.691 -10% Q4 2025 -6% excl. Fx 2024 2025 110,5 110,5 0% FY 2025 3% excl. Fx Comments • Germany had a split year, with strong performance in H1 (+13%), but sales decline in H2, leading to fully year growth of 3% • Sales performance reflects the unusual swings in ICU patient numbers during 2025 • Existing customers represent almost 70% of ICU ventilator beds in Germany, meaning the largest opportunity lies in increasing penetration in existing accounts, besides targeted pursuit of select new customers. • Still significant opportunity to grow: top- performing sales territories have penetration levels >20% and are still growing (vs. 14% national average in 2025)
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< Market headwinds from low patient numbers since May have affected H2 performance in Germany 8 0 20 40 60 80 100 120 140 160 180 0 5 10 15 20 25 30 35 40 45 50 Calendar week 2024 2025 Weekly number of severe acute respiratory infections with ICU treatment Source: Robert Koch Institut, based on 64 Sentinel hospitals -25% • Up until April 2025, the flu season in Germany was longer and more severe than 2024 • Since May, there were significantly less ICU cases with severe acute respiratory infections • As a result, customers have ordered less and later in the second half of the year Comments +12%
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< Distributor markets delivered a strong Q4 9 Net Sales MSEK 2024 2025 3,4 4,6 +38% Q4 2025 +44% excl. Fx 2024 2025 14,9 15,1 +1% FY 2025 4% excl. Fx Comments • Distributor market sales are generally more volatile due to irregular ordering patterns and higher stock levels • Focus of 2025 activities was on providing targeted support to prioritized partners, laying the groundwork for growth in 2026. • In parallel, 5 distributors without meaningful sales contribution were terminated.
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< US approval would meaningfully expand our addressable market Sources: Europe: based on publicly available data by country and Sedana Medical analysis USA: based on market assessment performed by external consultant company (Clarion Health) Europe (direct markets) United States ~1 million 3-4 BSEK 10-12 BSEK >2 million Ventilated adult ICU patients p.a. Market potential inhaled sedation (low- to mid-single digit growth p.a.) 10 • Only approved ICU therapy for inhaled sedation • Direct sales teams in Germany, UK, France, Spain, Benelux Status • Two successful pivotal trials completed • Fast Track Designation • Early Access Program approved
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< Our preparations for NDA submission are on track 11 Progress towards US approval ✓ Two successful Phase III trials - Primary endpoint met in both studies (incl. supplementary and sensitivity analysis) - No new safety findings - Expecting good level of differentiation from secondary endpoints ✓ Pooling analyses completed ✓ FDA Fast Track Designation (FTD) ✓ Early Access Program authorized by FDA Upcoming milestones • Successful pre-NDA meeting with FDA in Q4 2025, with good alignment on content, format and expectations for the submission • Aiming at NDA submission mid 2026, with 10 months standard review time (or 6 months in case of priority review)
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< Secondary endpoints showed several potential benefits (subject to approval and label decision by the FDA) 12 1 No statistically significant difference vs. propofol in individual studies Clinical results • Greater opioid reduction vs. baseline compared to propofol (approx. 31% and 37% reduction vs. baseline) Relevance in practice • Opioids cause (dose-dependent) issues in the ICU, such as constipation, respiratory depresssion, withdrawal and delirium • Opioid doses administered during mechanical ventilation are associated with persistent opioid use in the year after discharge • Fast return to wakefulness, typically within 60 minutes after treatment termination (ns1) • Long wake-up times are associated with unpredictable extubation, unreliable neurological assessments, unnecessary CT scans, prolonged ventilation and ICU length of stay • Longer wake-up times are common with IV sedatives (hours to days) • Numerically lower mortality (4 and 5 pp lower respectively at 30 days, ns1) • Safety incl. mortality is top of mind for HCPs, Pharmacy & Therapeutics Committees, and Group Purchasing Organizations • More ICU-free days for isoflurane patients in all 3 randomized trials (ns1) • >1 additional ICU-free day (average across 3 studies) would translate into potential cost saving for the hospital (cost of an ICU day 4-11 kUSD) • Minimal metabolism with isoflurane (unlike IV sedatives) • Isoflurane can be used in special populations (eg patients with renal and/or hepatic impairment) since elimination is almost exclusively via exhalation Other potential benefits Relevance in practice
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< INSPiRE-ICU1 • Vanderbilt • University of Colorado • Cleveland Clinic • UT Southwestern • Brigham & Women's Hospital • Mayo Clinic • University of Virginia • Intermountain • Tufts • Houston Methodist Hospital • MD Anderson • University of Cincinnati • Emory • University of Chicago INSPiRE-ICU2 • Rush University • Columbia University • Massachusetts General Hospital • University of Michigan • Beth Israel Deaconess MC • Ohio State Wexner • UCSD • UCLA • Stanford • Virginia Commonwealth • Long Beach Memorial • Thomas Jefferson University • University of Miami • University of Maryland • Henry Ford • Cooper Health • Memorial Hermann Hospital 31 prominent sites were involved in the trials – building a strong platform for KOL engagement and launch success 13
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< We are receiving good interest in our Early Access Program 14 • Approximately 10 prominent US hospitals have expressed interest in the EAP • First EAP patients expected to be treated in Q1 Status update • An FDA pathway to gain access to an investigational medical product before full market approval • FDA authorized the use of our therapy in “difficult-to- sedate" patients, when targeted sedation cannot be maintained with IV sedatives • The EAP is open to all interested hospitals in the US, products will be provided free-of-charge The EAP Besides helping difficult to sedate patients, the Early Access Program brings value: - The EAP includes a broad range of conditions - Continued use of inhaled isoflurane sedation during FDA review process - Hospitals and KOLs will gain proficiency and expertise that can be leveraged at launch - Opportunity to develop implementation, training, supply chain, etc., and to map external processes ahead of launch Benefits
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< We are preparing for launching ourselves in the US 15 1 Source: American Hospital Association Market • The United States have a market potential of 10-12 BSEK (vs. 3-4 BSEK in today’s direct markets) • Concentrated customer base: ~4.860 hospitals with ICU care (of which ~2.800 with >10 beds)1 • Strong product- market fit Strategy • Therefore, we are preparing to build a commercial US subsidiary and launch our therapy ourselves - Keep control of our assets and capture more of the upside - Increase the value by achieving proof of concept - Strong support from prominent clinical trial sites • Keep the option to add complementary partnership(s) if deemed attractive
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< Financial result in Q4 2025 Net sales Q4’25: 51.8 (49.2) MSEK, +5% y/y (+11% excl. fx) • Sales excluding contract manufacturing of 50.5 (48.4) MSEK, +4% y/y (+10% excl. fx). • Sales in Germany decreased 10% y/y (-6% excl. fx). Germany was negatively impacted by low ICU occupancy rate. • Other direct markets report growth of 25% y/y (+31% excl. fx), mainly driven by Spain. • Distributor market sales increased 38% y/y (+44% excl. fx) Gross Profit Q4’25: 37.6 (34.2) MSEK Gross Margin Q4’25: 72.7 (69.5) % • Positive effect from reduced cost of goods for our main product (Sedaconda ACD) following the acquisition of our supplier in Malaysia. EBITDA Q4’25: 0.1 (-5.5) MSEK EBITDA Ex-US Q4’25: 4.0 (-1.2) MSEK • Opex of 45 MSEK in Q4’25, which is in line with Q4’24, as we continue to find efficiencies in our organization to contain cost increases while growing sales. • EBITDA continues to improve despite market headwinds during 2H 2025. Staff incl. consultants at year-end 2025: 127, compared with 125 at year-end 2024. Excluding Innovatif Cekal, staff incl. consultants at year- end 2025 was 77, compared with 87 at year-end 2024. Net sales (MSEK, 12m rolling) Gross profit development (12m rolling) 16 60 80 100 120 140 160 180 200 Q1 2023 Q2 Q3 Q4 Q1 2024 Q2 Q3 Q4 Q1 2025 Q2 Q3 Q4 Net sales, 12m rolling (MSEK) 50% 55% 60% 65% 70% 75% 70 90 110 130 150 Q1 2023 Q2 Q3 Q4 Q1 2024 Q2 Q3 Q4 Q1 2025 Q2 Q3 Q4 Gross profit, 12 months rolling (MSEK) Gross margin, 12 months rolling (%)
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< Cash flow and available funds * Cash and short-term deposits • Cash per year-end 2025: 91 MSEK compared to 112 MSEK at Sep 30, 2025. • Change in cash of -21 MSEK mainly driven by investments in intangible assets of -11 MSEK, which are mainly US-related. • Cash flow from operations Q4’25: -5.2 (7.3) MSEK. • Operating income improved, but negative cash flow effects from less interest received and changes in working capital (increased operating receivables and decreased operating liabilities). • Cash flow from investing activities Q4’25: -12.7 (-55.1) MSEK • Driven by US capex (NDA submission preparations). • The comparator period includes net cash flow from the acquisition of Innovatif Cekal of -25.0 MSEK. • Total cash flow Q4’25: -19.1 (-48.6) MSEK. • Capex to stabilize at new lower level over the coming year. • We expect to be sufficiently financed to achieve US approval. Change in cash position (MSEK) excl short-term deposits Available funds* (MSEK) 17 -100 -80 -60 -40 -20 0 20 40 Q1 2024 Q2 Q3 Q4 Q1 2025 Q2 Q3 Q4 Cash flow from operations Cash flow from investing activities Cash flow from financing activities FX effect on cash balances 0 50 100 150 200 250 300 350 400 Q1 2024 Q2 Q3 Q4 Q1 2025 Q2 Q3 Q4
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< Largest shareholders Dec 31, 2025 18
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< 3 reasons to believe in Sedana Medical 19 A therapy with compelling benefits for patient and hospitals A profitable and growing core business in Europe An opportunity to enter the US, the highest potential market • Clinically proven benefits for ventilated intensive care patients • Health-economic benefits for the hospital • All-time-high sales in FY 2025 • Positive EBITDA ex-US in FY 2025 • Positive results in both pivotal Phase III trials • FDA fast track designation • Early Access approved • Positive pre-NDA meeting
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< Q&A